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While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.

A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.

- First study participant dosed in U.S. trial with healthy volunteers and patients with peanut allergy - Novel, human-derived, half-life extended tri-specific monoclonal antibody to prevent allergic reactions

Novo Nordisk has plummeted back to Earth after a stunning rise driven by Ozempic and Wegovy. Can the storied Danish pharma recover?

After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.

Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.

As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.

Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.